Ministry of Agriculture and Forestry, Finland NB: Unofficial translation; legally binding texts are those in Finnish and Swedish. Feed Act (86/2008, amendments up to 565/2014 included) Chapter 1 General provisions Section 1 Objective (1) The objective of this Act is to ensure the quality, safety and traceability of feeds and provision of appropriate information on feeds in order to safeguard the health of animals and good quality of foods of animal origin. Section 2 Scope (1) This Act applies to feeds and their handling, feed business operators, as well as control in all production, manufacturing and distribution stages of feeds from primary production to placing on the market and use. (2) This Act does not apply to feed that is used for feeding of animals used for scientific or education purposes. However, sections 10 a and 10 b apply to a substance to be used as additive in feed for farmed animals in a scientific experiment which has not been approved for this purpose. Section 3 European Union feed legislation (1) Unless otherwise provided in other law, this Act also applies to the control of the compliance with the following regulations of the European Union concerning feeds and feed control and provisions issued under them: 1) Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (General Food Regulation); 2) Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (Control Regulation); 3) Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene (Feed Hygiene Regulation); 4) Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (Additives Regulation); 5) Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal By-Products Regulation); 6) Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; 7) Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (GM Food and Feed Regulation);
8) Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (GMO Traceability Regulation); 9) Regulation (EC) No 1946/2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms; 10) Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSE Regulation); 11) Regulation (EC) No 2160/2003 of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents; 12) Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (Placing on the Market and Use Regulation); 13) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs; 14) Council Regulation (EC) No 834/2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91. Section 4 Relationship with other legislation (1) Provisions on the import and import control of feeds of animal origin from states outside the European Community are laid down in the Act on Veterinary Border Inspection (1192/1996). The Radiation Act (592/1991) applies to the criteria for assessing the radiation safety of feeds. Provisions on the contained use and release of genetically modified organisms and taking into use and activities of an establishment or premises intended for the handling of genetically modified organisms are laid down in the Gene Technology Act (377/1995). Provisions on the manufacturing, imports, distribution, sale and other release to consumption of medicated products are laid down in the Medicines Act (395/1987). Provisions on the use and control of medicines and other substances used for treating animals and use and control of implements to be used in the medication of animals are laid down in the Act on the Medication of Animals (617/1997). Provisions on the requirements for operators and establishments in the field as well as granting of permits and control are laid down in the Act on Protection of Animals Used for Scientific and Education Purposes (497/2013). Section 5 Definitions (1) In this Act: 1) feed means feed defined in Article 3(4) of the General Food Regulation; 2) feed material means feed material defined in Article 3(2)(g) of the Placing on the Market and Use Regulation; 3) compound feed means compound feed defined in Article 3(2)(h) of the Placing on the Market and Use Regulation; 4) feed batch or lot means batch or lot defined in Article 3(2)(r) of the Placing on the Market and Use Regulation; 5) feed additive means feed additive defined in Article 2(2)(a) of the Additives Regulation; 6) genetically modified feed means feed defined in Article 2(7) of the GM Food and Feed Regulation;
7) medicated feed means a mixture of a veterinary medicine or medicines and feed manufactured for placing on the market and intended to be fed to animals as such due to properties that cure or prevent illness or other medicinal properties; 8) feed intended for particular nutritional purposes means feed intended for particular nutritional purposes defined in Article 3(2)(o) of the Placing on the Market and Use Regulation; 9) undesirable substance, product and organism means a substance, product and organisms in feed which may endanger animal health or, via products of animal origin, human health or the environment; 10) label means a label defined in Article 3(2)(t) of the Placing on the Market and Use Regulation; 11) feed business operator means a natural or legal person who engages in any production, manufacturing or distribution stage of feed as well as an operator who uses feed for feeding food-producing animals he or she owns or keeps; however, an operator shall not be considered a feed business operator if he or she engages solely in: a) feeding of food-producing animals intended for private household use only; b) manufacturing of feed for animals other than food-producing animals he or she own or keeps; c) retail trade in pet food; d) fishing for stock management purposes or recreational fishing. 12) primary production of feed means primary production of feed defined in Article 3(f) of the Feed Hygiene Regulation; 13) business operator in the primary production of feed means a business operator who engages in the activities listed in Article 5(1)(a) (c) of the Feed Hygiene Regulation and a business operator who uses feed for feeding food-producing animals that he or she owns or keeps; 14) production, manufacturing and distribution stage means any stage from the primary production of feed to the delivery of feed to the final user; 15) establishment means any unit of a feed business that carries out a feed production, manufacturing and distribution stage; 16) own-checks mean a control system of a feed business operator by which the operator aims to ensure that the feed and its handling fulfil the requirements set for them; 17) sample means an entity composed of one or several incremental samples taken from a feed batch or lot or part thereof; 18) country of origin means the country from which a feed batch or lot is imported to Finland; 19) method for calculation means the formulae and constants of the Natural Resources Institute Finland (until 31 December 2014 Agrifood Research Finland), the digestibility coefficients given in the feed tables and, for ruminant feed, also the proportion of degradable protein; (565/2014) 20) placing on the market means the placing on the market of feeds defined in Article 3(8) of the General Food Regulation; 21) traceability means the possibility to trace feed in all production, manufacturing and distribution changes as well as to monitor it within these stages; 22) imports mean imports from a country other than a Member State of the European Union; 23) exports mean exports to a country other than a Member State of the European Union; 24) internal market trade means imports from another Member State of the European Union to Finland and exports from Finland to another Member State of the European Union; 25) salmonella bacterium means all bacteria of the genus Salmonella; 26) farmed animal means an animal referred to in Chapter 1, Article 3(6) of the Animal By- Products Regulation.
(2) The provisions laid down in this Act on the European Union or Member States of the European Union shall also apply to the European Economic Area and the states belonging to it. Chapter 2 Requirements concerning feeds Section 6 General quality requirements for feeds (1) Feeds shall comply with the requirements of this Act and the feed legislation of the European Union and they shall be genuine, of good quality and safe as well as appropriate for animal nutrition. Provisions on the general requirements concerning the safety of feeds are also laid down in Articles 11 and 15 of the General Food Regulation and on the specific conditions for feeds exported from the Community in Article 12 of the General Food Regulation. (2) Feed may not contain undesirable substances, products or organisms in a way that its use may endanger human or animal health or the environment or quality defects in products of animal origin. No salmonella bacteria may be present in the feed. (3) Provisions on the maximum content of undesirable substances and products in feeds are laid down in the Commission implementing acts amending Annex I to Directive of the European Parliament and of the Council 2002/32/EC on undesirable substances in animal feed. Section 7 Feed materials (1) Feed materials shall be appropriate for the feeding of animals as regards their quality, composition and other properties. (2) The European Union publishes a Community Catalogue of feed materials as specified in Articles 24 and 26 of the Placing on the Market and Use Regulation. (3) For compound feed intended for pets the name of the category to which the feed material belongs may be used instead of the specific name of the feed material as specified in Article 17 of the Placing on the Market and Use Regulation. (4) Further provisions on the feed material categories referred to in subsection 3 are issued by decree of the Ministry of Agriculture and Forestry. Section 9 Feeds intended for particular nutritional purposes (1) Feeds intended for particular nutritional purposes shall be appropriate for the particular nutritional needs of animals as regards their quality, composition and other properties. (2) Only feeds intended for particular nutritional purposes which the European Union has authorised to be included in the list of intended uses of feed intended for particular nutritional purposes may be manufactured, placed on the market, used for the manufacturing of feeds or feeding of animals and imported. Provisions on the procedure for updating the list of intended uses are laid down in Article 10 of the Placing on the Market and Use Regulation. (3) Further provisions on the conditions for the authorisation of feeds intended for particular nutritional purposes are laid down by decree of the Ministry of Agriculture and Forestry in accordance with the provisions laid down in the European Union feed legislation. (4) Provisions on amendments to the list of intended uses of feed intended for particular nutritional purposes are laid down by implementing acts amending Annex I to Commission Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes. Section 10 Feed additives
(1) Provisions on the authorisation and placing on the market of feed additives are laid down in Articles 3 5 of the Additives Regulation. Section 10 a Permit to use an unapproved feed additive 1) A feed business operator who intends to use a substance as a feed additive in a scientific experiment performed on farmed animals which has not been approved for this purpose shall apply to the Finnish Food Safety Authority for a permit for such use. The Finnish Food Safety Authority may grant a permit to use such a substance in a scientific experiment if demonstrating its efficacy in a production experiment is required for the approval of the substance. The permit is granted if the experiment is not considered likely to have adverse impacts on the health of humans or farmed animals or the environment. 2) The applicant for the permit shall designate a responsible person for the experiment. A plan on the experiment shall be attached to the application for permit, showing the data on the substance to be used, its purpose of use, use levels, farmed animals to be used in the experiment, experiment design and duration of the experiment. 3) Further provisions on the permit application procedure and content of the permit application are issued by decree of the Ministry of Agriculture and Forestry. Section 10 b Interrupting a scientific experiment 1) The experiment referred to in section 10 a above shall be interrupted if during the experiment it turns out that the substance has significant adverse impacts on the health of humans or farmed animals or the environment which could not be foreseen when the permit was granted. The person responsible for the experiment shall notify the Finnish Food Safety Authority of the matter without delay. Section 11 Genetically modified feeds (1) Provisions on the approval and placing on the market of feeds falling within the scope of the GM Food and Feed Regulation are laid down in Articles 17 19 of the GM Food and Feed Regulation. (2) Further provisions on the national contact authority, safety assessment of genetically modified feeds and establishment of the national position concerning the authorisation of feeds required by the GM Food and Feed Regulation are issued by government decree. Section 12 Compound feeds (1) Compound feeds shall be appropriate for the feeding of animals as regards their quality, composition and other properties. Compound feed may contain only feeds referred to in sections 7 11 which fulfil the requirements laid down for it. Section 13 Medicated feeds (1) Only medicines authorised through the centralised procedure of the European Community or whose sale or other release to consumption has been authorised by the Finnish Medicines Agency by virtue of the Medicines Act may be used for the manufacturing of medicated feed. (2) An operator who manufactures medicated feeds and places them on the market shall keep a file on the information relating to their manufacturing and release. Medicated feeds shall be stored, packaged and transported in an appropriate manner.
(3) The manufacturer and retailer may hand over medicated feed to the owner or keeper of the animal only against a prescription written by a veterinarian. (4) In addition to the provisions in subsections 1 3, the provisions on compound feeds apply to medicated feeds. (5) Further provisions on the requirements for the manufacturing of medicated feed, bookkeeping concerning the manufacturing and release, organisation of the activities, prescribing and releasing medicated feed and imports are issued by decree of the Ministry of Agriculture and Forestry. Section 14 General requirements concerning information to be given on feed (1) Truthful and sufficient information on feed shall be given in the feed package, label, accompanying document, brochure or advertisement or otherwise in connection with marketing or presentation of feed. (2) Provisions on the principles of the claims to be allowed in the labelling and presentation of feed materials and compound feeds are laid down in Article 13 of the Placing on the Market and Use Regulation. Section 15 Labelling requirements for feeds (1) Provisions on the compulsory labelling of feed materials and compound feeds and their presentation are laid down in the Placing on the Market and Use Regulation, TSE Regulation, GM Food and Feed Regulation, GMO Traceability Regulation and Animal By-Products Regulation. Other information may also be given on feed materials and compound feeds, provided that the general principles of the Placing on the Market and Use Regulation are complied with and the information is unambiguous, measurable and justifiable. Provisions on the labelling requirements for feed additives and premixtures are laid down in the EC Additives Regulation. (2) Provisions on the labelling of a feed material or compound feed which does not comply with the law are laid down in Article 20 of the Placing on the Market and Use Regulation. (3) Labelling of feeds intended directly or indirectly to the final user shall be at least in the Finnish and Swedish language. However, in feed sold only in a monolingual municipality monolingual labelling only in the language of the municipality may be used. In a bilingual municipality feed packaged at the place of sale and bulk feed supplied by the producer directly to the final user and feed supplied by an operator in primary production in the feed sector to another operator in primary production in the feed sector may be labelled using the language of the final user in question in either Finnish or Swedish. (4) The energy and protein values given for feed materials and compound feeds shall be based on the calculation methods published by the Natural Resources Institute Finland (until 31 December 2014 Agrifood Research Finland) unless otherwise provided in the European Union legislation. (565/2014) (5) Further provisions on the specification, presentation and marking of the energy and protein values of feed materials and compound feeds are issued by decree of the Ministry of Agriculture and Forestry. Section 15 a Packaging requirements for feed (1) Feeds shall be packaged in a way that is safe and appropriate considering the properties of the product.
(2) Provisions on the packaging requirements for feed are laid down in Article 23 of the Placing on the Market and Use Regulation and on the packaging requirements for additives and premixtures in Article 16 of the EC Additives Regulation. Section 16 Temporary restrictions (1) Where there is justifiable cause to suspect that feed may seriously endanger human or animal health or the environment, the manufacturing, placing on the market, use, imports or exports of the feed may be temporarily prohibited or restricted by decree of the Ministry of Agriculture and Forestry and the prohibited feeds may be ordered removed from the market or from the stocks of places of primary production and other possessors of feed. Provisions may also be laid down by decree that the Finnish Food Safety Authority may in individual cases grant a derogation from the prohibition or restriction laid down in the said decree if it can be ensured that the feed concerned in the derogation does not endanger human or animal health or the environment. Chapter 3 Requirements concerning the pursuit of activities Section 17 Organisation of activities (1) A feed business operator is obliged to organise the activities in a way that the requirements laid down for the activities and feeds in the European Community feed legislation as well as in this Act and under it are fulfilled. Provisions on the responsibility of feed business operators for the safety of feeds are also laid down in Article 17(1) of the General Food Regulation. (2) Provisions on the obligation of a feed business operator to organise the quality control of the activity are laid down in Article 5 7 of the Feed Hygiene Regulation. (3) A feed business operator shall have appropriate facilities, devices and equipment in the production, manufacturing and distribution stages of the feeds. Sufficient care and caution shall be taken in the handling, use, transport and storage of feeds to prevent health, safety and environmental damages. (4) Further provisions on the handling, use, transport and storage requirements for feeds as well as own-checks by the operators and examinations to be made in own-checks and measures when feed that violates the rules are found are issued by decree of the Ministry of Agriculture and Forestry. Section 18 Notification obligation of a feed business operator (1) A feed business operator shall notify the Finnish Food Safety Authority in writing of its activities and significant changes in them as well as cessation of the activities with a view to registration as specified in Article 9 of the Feed Hygiene Regulation. However, the notification obligation shall not apply to feed business operators which only supply small quantities of primary products they have produced directly to a local farms to be used there. (2) The notification shall include the following information: 1) the name and address of the operator and other contact information for each establishment; 2) the business or company identification number of the operator or, if none exists, personal identification number or farm identification number; 3) the type of activities or significant changes in them. (3) A feed business operator referred to in subsection 1 above shall notify the Finnish Food Safety Authority once a year in the way requested by it of the quantities of feeds manufactured, feeds used in the manufacturing and their origin, and feeds placed on the market, imported and exported and their quantities.
(4) Further provisions on the information to be given in the notification and notification procedure may be issued by decree of the Ministry of Agriculture and Forestry. Section 19 Requirements concerning the recording and traceability of information (1) A feed business operator shall keep a file on information relating to its activities where information necessary for the control and traceability of feeds can be accessed, where necessary. Provisions on the obligation to record information are also laid down in Article 18(2) and (3) of the General Food Regulation, Annexes I and II to the Feed Hygiene Regulation and Annex II to the Animal By-Products Regulation. The recording obligation applies to information which allows to trace the feed and monitor the use of production inputs and management of the production processes. (2) Further provisions on the content, organisation and storage of the file are issued by decree of the Ministry of Agriculture and Forestry. Section 20 Approval of a feed business operator (1) A feed business operator shall before starting the activities apply to the Finnish Food Safety Authority for the approval of the activities if the intention is to carry out activities referred to in Article 10 or subparagraph 10 of paragraph "Facilities and equipment" of Annex II to the Feed Hygiene Regulation, activities subject to approval referred to in Annex IV to the TSE Regulation or Article 8(2) of the Placing on the Market and Use Regulation, activities referred to in paragraph 1 of Annex VIII to the Placing in the Market and Use Regulation or manufacturing or placing on the market of medicated feeds. Provisions on the conditions for the approval under the Feed Hygiene Regulation and TSE Regulation are laid down in Article 13 of the Feed Hygiene Regulation and Annex IV to the TSE Regulation. (2) The application concerning approval shall include the following information: 1) the name and address of the operator and other contact information for each establishment; 2) the business or company identification number of the operator or, if none exists, personal identification number or farm identification number; 3) the type of activities or significant changes in these; 4) point of time when the activities or activities subject to change are to be started. (3) A significant change in the activities of an approved establishment shall also have been approved before the activities subject to change are started. The operator shall give the control authority an opportunity to carry out an inspection in the production units and other facilities before the activities are started. (4) A feed business operator shall be approved if the requirements laid down in the Feed Hygiene Regulation and TSE Regulation are fulfilled. The approval may be issued as a conditional one as specified in Article 13(2) of the Feed Hygiene Regulation. Requirements, restrictions and other conditions concerning the activities may be imposed to an approved operator for advance prevention of risks to human or animal health or the environment. (5) Further provisions on the content of the information to be given in an application concerning approval and the application procedure are issued by decree of the Ministry of Agriculture and Forestry. Section 21 Obligation of a feed business operator to provide information (1) If a feed business operator has cause to suspect that feed it has placed on the market or used does not fulfil the requirements concerning the safety of feeds or it is found in own-checks that the maximum permitted levels of undesirable substances, products or organisms have been
exceeded, the Finnish Food Safety Authority shall be notified of this immediately. To prevent risks caused by feed placed on the market the operator who placed the feed on the market shall notify the operator to whom the feed was supplied immediately of any salmonella findings in the feed. The operator using the feed shall notify the manufacturer of the feed immediately if a decision based on official suspicion of salmonella infection or confirmed salmonella infection referred to in section 23 of the Animal Disease Act (441/2013) has been issued to the place where animals are held referred to in the Act on the Animal Identification System (238/2010). (2) A feed business operator shall notify the Finnish Food Safety Authority without delay of any test results indicating feed that violates the rules if the test was conducted by a laboratory referred to in section 28 b, as well as give instructions to the laboratory for submitting the notifications and summaries referred to in section 28. (3) Further provisions on making the notification may be issued by decree of the Ministry of Agriculture and Forestry. (4) Provisions on withdrawing feed that violates the rules from the market are laid down in Article 20 of the General Food Regulation. Chapter 4 Authorities and their tasks Section 22 General steering and control (1) The general steering and control of the implementation of the feed legislation of the European Community and this Act are the task and responsibility of the Ministry of Agriculture and Forestry. Section 23 Control authorities (1) The Finnish Food Safety Authority plans, steers, develops and carries out national feed control as provided in this Act as well as sees to the related communication. In the control the Finnish Food Safety Authority may seek the assistance of the Centres for Economic Development, Transport and the Environment. (2) Besides the Finnish Food Safety Authority, medicated feeds are controlled by the Regional State Administrative Agencies (3) Besides the Finnish Food Safety Authority, imports and exports of feed and transit transport of feed via Finland are controlled by the Finnish Customs. (4) Veterinary Officers for Border Inspection see to the control under this Act in veterinary border inspections. Section 24 Authorised inspectors (1) In addition to the provisions in Article 23, for the control the Finnish Food Safety Authority may seek the assistance of inspectors it has authorised in writing who operate under the control of the Finnish Food Safety Authority when carrying out their task. Provisions on the criminal liability for acts in office apply to inspectors when they carry out tasks under this Act. The provisions of the Tort Liability Act (412/1974) apply to damage caused upon the management of the tasks by the inspector. For managing their tasks the inspectors shall have sufficient professional skills concerning feeds or otherwise necessary for controlling the compliance with this Act. (2) The provisions of the Administrative Procedure Act (434/2003), Language Act (423/2003) and Sámi Language Act (1086/2003) apply to authorised inspectors when they carry out tasks under this section. The provisions on the publicity of the documents given to or prepared by the
inspector, obligation of secrecy and implementation of the publicity of a document are laid down in the Act on the Openness of Government Activities (621/1999). (3) When required by a feed business operator the authorised inspector shall present an account in writing of his or her authorisation. Chapter 5 Laboratories Section 25 Testing of samples (1) Samples taken or commissioned to be taken by a control authority for control under this Act (official sample) shall be tested in a laboratory approved to test official samples or in a national reference laboratory. (2) Samples taken in own-checks concerning salmonella required by law shall be tested in an approved own-check laboratory, laboratory approved to test official samples or national reference laboratory. (3) Provisions on samples taken in own-checks concerning dioxin are laid down in the Feed Hygiene Regulation. Section 26 National reference laboratories (1) The Ministry of Agriculture and Forestry designates the national reference laboratories and specifies their tasks. Provisions on the requirements concerning the national reference laboratories and the tasks of the laboratories are laid down in Article 33 of the Control Regulation. Section 27 Approved laboratories (1) The Finnish Food Safety Authority approves the laboratories which test official samples and own-check laboratories upon application. A laboratory may also have a mobile unit. (2) A condition for the approval of an own-check laboratory is that fulfilling the qualification requirements has been proven in accordance with the provisions of the Act on Verification of Qualifications of Services for Assessing Compliance with the Requirements (920/2005) on the basis of an accreditation or assessment of the qualifications. The qualifications of a laboratory shall be reassessed at least every three years. (3) A laboratory which tests official samples shall fulfil the requirements laid down in Article 12(2) of the Control Regulation. (4) If a laboratory does not fulfil the requirements laid down in this section but the shortcomings are such that the reliability of the tests is not compromised, the Finnish Food Safety Authority may approve the laboratory for a fixed period. The laboratory shall remedy the shortcomings and apply for the final approval within the fixed time period. (5) For advance prevention of danger to human or animal health or the environment, requirements, restrictions and other conditions concerning the activity may be imposed to the approved laboratory. (6) Further provisions on the standards indicating the qualifications of approved laboratories, requirements to be set for the quality systems of laboratories and other requirements for the approval of laboratories may be issued by government decree. Section 28 Notification obligation of approved laboratories (1) An approved laboratory shall notify the party that commissioned the test without delay of any test results indicating feed that violates the rules.
(2) An approved laboratory shall also notify the Finnish Food Safety Authority of tests and their results relating to the monitoring and control of diseases or infections which may be transmitted directly or indirectly between humans and animals (zoonoses) and deliver the microbial strains isolated in the tests to the national reference laboratory. (3) Upon request of the Finnish Food Safety Authority, an approved laboratory shall submit a summary of the tests referred to in section 25(1) and (2) it has conducted and their results. The summaries of tests and their results referred to in section 25(2) above may contain no personal data or identification data of the object of control. (4) An approved laboratory shall notify the Finnish Food Safety Authority without delay of any significant changes in the activities, suspension of activities and cessation of activities. (5) Further provisions on the content and submission of the notifications and summaries and delivery of microbial strains are issued by government decree. Section 28 a Notification obligation of a national reference laboratory (1) Upon request, a national reference laboratory shall notify the Finnish Food Safety Authority and the National Institute for Health and Welfare of information necessary for epidemiological monitoring as well as the Finnish Food Safety Authority of information on microbial strains referred to in section 28(2) necessary for steering the control. The information to be submitted to the National Institute for Health and Welfare may contain no identification data on the objects of control. (2) Further provisions on the content and submission of the notifications may be issued by government decree. Section 28 b Designated laboratories 1) The Finnish Food Safety Authority may designate a laboratory located in another Member State of the European Union to test own-check samples taken for salmonella as required by law. 2) The Finnish Food Safety Authority designates the laboratories referred to in subsection 1 upon application by the feed business operator. A condition for the designation is that the laboratory fulfils the requirements in Article 12(1) of Regulation of the European Parliament and of the Council (EC) No 2160/2003 on the control of salmonella and other specified food-borne zoonotic agents concerning the quality assurance system and the quality assurance system concerned has been verified by a competent body of the Member State concerned. 3) Designation need not be applied for if the laboratory fulfils the requirements laid down in section 12(2) of the Control Regulation. 4) Further provisions on the application procedure and designation of laboratories are issued by decree of the Ministry of Agriculture and Forestry. Chapter 6 Control Section 29 Organisation of control (1) Feeds and feed business operators shall be controlled in an equitable manner and on a regular basis. The control shall be intensified if it is to be suspected that the feed or the activities of the feed business operator do not fulfils the requirements laid down in the European Union feed legislation or in this Act or under it. Control measures shall be appropriate and fit for their purpose, and they shall be targeted in an appropriate manner to all production, manufacturing and distribution stages of feeds from primary production to placing on the market and use. (2) The control authority shall, where necessary, advise a feed business operator on how to comply with the requirements of the European Union feed legislation and this Act and laid down under
it. Further provisions on the organisation of the control may be issued by decree of the Ministry of Agriculture and Forestry. (3) Provisions on the organisation of control are also laid down in the European Union legislation concerning the control, safety and health quality of feeds and feed hygiene. Section 30 Control of laboratories (1) The Finnish Food Safety Authority controls that the laboratories which conduct tests referred to in section 25 comply with this Act and provisions issued under it. Section 32 Prior notification and sampling from feed to be imported (1) A feed business operator shall notify the Finnish Food Safety Authority of feed batches or lots to be imported referred to in Article 15(5) and paragraph 2 of Article 17(1) of the Control Regulation for possible sampling before the receipt of the batch or lot. (2) The following information shall be given in the prior notification: 1) name and address of the importer; 2) the business or company identification number of the importer or, if none exists, personal identification number or farm identification number; 3) name and type of feed; 4) quantity of the feed batch or lot; 5) country of origin; 6) time and place of entry in the Finnish territory; 7) method of import. (3) By order of the control authority, feed to be imported may be kept under the supervision of the Finnish Customs in a place approved by the control authority until the control authority has received sufficient proof that the requirements laid down in the European Union feed legislation and in this Act and under it are fulfilled. (4) Further provisions on how and when the prior notification of feed batches or lots referred to in subsection 1 by a feed business operator to the Finnish Food Safety Authority is to be made as well as how the sampling and other import inspections are to be carried out are issued by decree of the Ministry of Agriculture and Forestry. Section 33 Control plan (1) The Finnish Food Safety Authority shall prepare the multi-annual national control plan referred to in Article 42 of the Control Regulation, which describes the structures and organisations of the systems relating to feed control as well as the strategic objectives, prioritisation and general organisation of the control. (2) In addition to the multi-annual national control plan, the Finnish Food Safety Authority shall prepare an annual control plan on the organisation of feed control. The annual control plan shall specify the content of the inspections to be carried out as well as inspection frequency of objects of control. The control plan shall also present the grounds of the risk assessment of objects of control and of assessing the realisation of the plan. (3) Further provisions on the control plans and their content may be issued by decree of the Ministry of Agriculture and Forestry. Section 34 Right to inspect and to access information (1) The control authority and authorised inspectors have, for the control purpose, the right to undertake measures laid down in this Act and European Union legislation, gain access to
premises where feeds and documents concerning them are handled, used or kept, inspect means of transport, records of feed business operators and a file referred to in section 19, as well as take necessary samples from feeds free of charge. In premises used for residential purpose on a permanent basis an inspection may be carried out only by an authority. In such premises an inspection may be carried out only if it is absolutely necessary to clarify matters to be inspected and there is justifiable cause to suspect that a certain party is guilty of conduct that is subject to penalty under this Act and the inspection is necessary to solve a crime. (2) The control authority and authorised inspectors have the right to obtain information and documents necessary for inspection and control laid down in this Act and in the European Union legislation from the feed business operator. Where required, a feed business operator shall provide all information necessary for inspection and control to the control authority and authorised inspectors. (3) The provisions in subsections 1 and 2 on the right to inspect and to access information of the Finnish authorities shall also apply to inspectors of the European Union. In these inspections the control authority shall cooperate with the inspectors of the European Union. (4) Further provisions on the inspection and control procedure as well as sampling and testing of samples may be issued by decree of the Ministry of Agriculture and Forestry. Section 35 Disclosure of secret information (1) Information obtained in control is to be kept secret as provided in the Act on the Openness of Government Activities and Article 7 of the Control Regulation. (2) The obligation of secrecy notwithstanding, in addition to the provisions of the Act on the Openness of Government Activities information obtained in control may be disclosed to: 1) authorities referred to in section 23 for managing tasks under this Act; 2) prosecution, police and customs authorities for solving a crime. Section 36 Control register (1) For the control purpose the Finnish Food Safety Authority shall keep a national register of feed business operators subject to the notification obligation referred to in section 18, approved laboratories referred to in section 27 and designated laboratories referred to in section 28 b. Section 37 Information to be entered in the control register (1) Information on the feed business operator to be entered in the control register shall include: 1) name and address and other contact information of the feed business operator; 2) addresses and contact information of the places of business; 3) the business or company identification number of the feed business operator or, if none exists, personal identification number or farm identification number; 4) description of the activities; 5) approval number if approval is one granted under the Feed Hygiene Regulation, 6) information on an order, prohibition, penalty or other sanction issued to the operator under sections 40 42 and 45 or 46 or Articles 14 16 of the Feed Hygiene Regulation; 7) control measures carried out as well as other similar information under this Act or provisions issued under it necessary for the control. (2) Information on the approved and designated laboratories to be entered in the control register shall include: 1) name and address and other contact information of the laboratory; 2) analytical methods covered by approval or accreditation; 3) analytical method of a laboratory referred to in section 28 b;
4) name of the person responsible for testing in the laboratory; 5) information on withdrawal of approval under section 44 or withdrawal of designation under section 44 a or other sanction; 6) control measures carried out in approved laboratories as well as other similar information under this Act or provisions issued under it necessary for the control. (3) The Finnish Food Safety Authority publishes a list of feed business operators and approved laboratories on the basis of information referred to above in subsections 1 and 2. (4) Information on feed business operators shall be removed from the register within ten years and information on approved laboratories within three years from the operator or laboratory having notified the control authority of the cessation of the activity or from the cessation of the activity. However, a register entry on a penalty shall be removed when the cause for the deed being punishable that was the reason for sentencing to the penalty has been removed. If information entered to the register is based on a decision that is not legally valid and the decision is subsequently repealed, the information shall be removed not later than when the decision concerning the repeal has become legally valid. (5) Otherwise the provisions of the Personal Data Act (523/1999) and Act on the Openness of Government Activities apply to the handling of personal data. (6) Further provisions on entering feed business operators to the register may be issued by decree of the Ministry of Agriculture and Forestry. Section 38 Obligation of the control authority and authorised inspector to provide information (1) If the control authority or authorised inspector knows or has cause to suspect that that feed or its use may endanger human or animal health or the environment, the control authority and authorised inspector shall, the provisions on secrecy notwithstanding, notify the competent environmental, food, veterinary or health protection authority of this. The notification shall always be made to the Finnish Food Safety Authority as well. The Finnish Food Safety Authority shall notify the National Institute for Health and Welfare if feed or its use may endanger human health. (2) The control authority or authorised inspector is obliged to notify the Finnish Food Safety Authority of information needed for the register it maintains under section 36. In addition, the control authority is obliged to notify, upon request, the Finnish Food Safety Authority of other information concerning inspections, control measures, control staff, charges and control for the monitoring of the control under this Act. (3) The control authority and authorised inspector shall submit the information referred to in subsections 1 and 2 in a way required by the Finnish Food Safety Authority. (4) Further provisions on the notification obligation of the control authority and authorised inspector may be issued by government decree. Section 39 - Publication of control results (1) The Finnish Food Safety Authority shall publish the control results. Information to be kept secret referred to above in section 35 may, however, not be published. (2) Further provisions on the publication of the control results may be issued by decree of the Ministry of Agriculture and Forestry. Chapter 7 Administrative enforcement measures and sanctions Section 40 Removing a shortcoming
(1) The control authority may order a shortcoming to be removed if feed or information provided on it, the production, manufacturing or distribution stage of feed or the production facilities, place of primary production or the activity practised in these may endanger health, compromise the correctness or sufficiency of information provided on feed or mislead the consumer or otherwise fail to comply with the requirements of the feed legislation. A shortcoming shall be ordered removed immediately or within a time period set by the control authority. Section 41 Prohibition (1) The control authority may prohibit: 1) the production and manufacturing of feed if the production, manufacturing or storage facilities, manufacturing methods or equipment or the quality control systems or products of the manufacturer do not fulfil the requirements laid down for them in the European Union feed legislation or in this Act or under it; 2) handling of feed if the handling or storage facilities, handling methods or equipment or quality control methods or products of the feed business operator do not fulfil the requirements laid down for them in the European Union feed legislation or in this Act or under it; 3) placing on the market or use of feed if: a) feed, its packaging or information provided on it do not fulfil the requirements laid down in the European Union feed legislation or in this Act or under it; b) feed is used contrary to the instructions for its use; c) the manufacturer, placer on the market or user of feed has neglected the notification obligation under section 18; d) the manufacturer, placer on the market or user has not been approved in accordance with section 20; or e) salmonella bacterium has been found in the production environment or transport equipment of feed; 4) transport or storage of feed if the transport equipment or storage facilities do not fulfil the requirements laid down in the European Union feed legislation or in this Act or under it; 5) internal market trade, imports or exports of feed if the feed does not fulfil the requirements laid down in the European Union feed legislation or in this Act or under it. (2) A prohibition may be issued only if the shortcoming may endanger human or animal health or the environment, if it continues or is repeated, or if it is caused intentionally. (3) A prohibition shall be issued as a temporary one if the shortcoming it is based on can be removed. A temporary prohibition remains in force until the control authority issues its final decision on the matter. A prohibition shall be withdrawn without delay if the shortcoming it is based on has been removed or if it is no longer relevant in terms of imposing the prohibition. (4) A prohibition shall be complied with in spite of appeal unless the appellate authority prohibits the enforcement of the decision by the control authority or orders it suspended. Section 42 Reprocessing, disposal and return of feed (1) If the control authority has issued a prohibition concerning the production, manufacturing, handling, placing on the market, use, internal market trade, imports or exports of feed under section 41, the Finnish Food Safety Authority may order the feed to be reprocessed, disposed of, used for another purpose or returned to the country of origin in a way approved by the Finnish Food Safety Authority and at the cost of the feed business operator. The decision may be accompanied by regulations concerning the procedure to be followed in its enforcement.
Section 43 Suspension, amending and withdrawal of the registration and approval of a feed business operator (1) Provisions on the suspension, amending and withdrawal of the registration and approval of a feed business operator are laid down in Articles 14 16 of the Feed Hygiene Regulation. Section 44 Withdrawal of the approval of a laboratory (1) The Finnish Food Safety Authority shall withdraw the approval of a laboratory if the laboratory ceases the activities on the grounds of which it has been approved. (2) In addition, the Finnish Food Safety Authority may withdraw the approval of a laboratory if the laboratory or activities practised in it significantly violate the requirements laid down in this Act or under it and the laboratory does not, in spite of an order of the Finnish Food Safety Authority, remedy the shortcomings within a reasonable time period. However, the approval may be withdrawn immediately if this is necessary due to unreasonable damage caused by the activity to human or animal health or the environment. (3) The Finnish Food Safety Authority may also withdraw the approval of a laboratory for the time needed for processing a matter referred to in subsection 2 if the shortcoming in the activities of the laboratory is such that it may compromise the reliability of the test results. Section 44 a Withdrawal of the designation of a laboratory 1) The Finnish Food Safety Authority shall withdraw its decision concerning the designation of a laboratory at the request of a feed business operator referred to in section 28 b or if it comes to the knowledge of the Finnish Food Safety Authority that the laboratory ceases its activity. 2) The Finnish Food Safety Authority may also withdraw its decision concerning the designation of a laboratory if it comes to the knowledge of the Finnish Food Safety Authority that the laboratory or activities practised in it significantly violate the requirements laid down in this Act or under it. 3) The Finnish Food Safety Authority may also withdraw its decision concerning the designation of a laboratory for the time needed for processing a matter referred to in subsection 2 if the shortcoming in the activities of the laboratory is such that it may compromise the reliability of the test results. Section 44 b Withdrawal of a permit 1) The Finnish Food Safety Authority may withdraw a permit referred to in section 10 a if the permit holder significantly violates the permit conditions laid down in this Act. Section 45 Notice of a conditional fine and enforced compliance (1) The Finnish Food Safety Authority may reinforce an order referred to in section 40, a prohibition referred to in section 41, or an order concerning reprocessing, disposal or return of feed referred to in section 42 by a notice of a conditional fine or notice that the neglected action is to be taken at the defaulter's expense. (2) The provisions of the Act on a Notice of a Conditional Fine (1113/1990) apply to a matter concerning a notice of a conditional fine and enforced compliance and taking action at the defaulter's expense. Section 46 Penal provision